by Dan Roberts
[It was reported on 2/9/12 that Phase III of this study did not meet it’s primary endpoint at 2 years. The information in this article describes the progress up to that point.]
NeoVista, Inc. announced on June 17, 2007 the official commencement of the CABERNET (Cnv secondary to Amd treated with BEta RadiatioN Epiretinal Therapy) clinical trial for the treatment of subfoveal choroidal neovascularization associated with wet AMD. The proprietary Epi-Rad90ª Ophthalmic System, developed by NeoVista, is being utilized in the CABERNET clinical trial.
Dr. Nelson Sabates (Professor and Chairman, Department of Ophthalmology, University of Missouri-Kansas City (UMKC)/Truman Medical Centers and Director of Vision Research Center, University of Missouri-Kansas City at Truman Medical Centers) treated the first patient enrolled in the CABERNET study. When asked for initial feedback on the procedure, Dr. Sabates commented, “It was no different than performing a common vitrectomy and the Epi-Rad delivery device allowed me to deliver a well focused dose of radiation to the lesion. Treating neovascular AMD using a multi-faceted approach like the use of radiation and anti-VEGF therapy may well be the next frontier in combating this sight threatening disease.”
The CABERNET clinical trial will involve clinical sites in the United States, Europe, Israel, and South America. The trial protocol is divided into two treatment arms: investigational and control.
The investigational treatment arm consists of concomitant delivery of Beta radiation, via the Epi-Rad delivery device, and the anti-VEGF agent Lucentis. The investigational treatment is administered during an outpatient surgical procedure and delivers Beta radiation directly to the area of the retina that has been compromised by the disease. An injection of the anti-VEGF agent is administered at the time of surgery with one additional injection administered 30 days after surgery. The control arm is utilizing Lucentis alone.
According to NeoVista, the benefits of radiation therapy over pharmacotherapeutic therapy are that the treatment is effective over a longer term, it mitigates the inflammatory and fibrotic responses, and it can be performed in a single out-patient treatment.
On October 15, 2010, NeoVista made public the company’s one-year results from the preliminary study MERITAGE-I. The study was designed to examine the epimacular brachytherapy procedure when used in patients that require chronic therapy with anti-VEGF agents on an ongoing basis to control their neovascular AMD. Study results to date suggested that a single procedure of epimacular brachytherapy can stabilize visual acuity in a majority of this patient population (79%) while decreasing the number of anti-VEGF injections required. Most importantly, 47% of patients enrolled in the study experienced some improvement in their visual acuity, while 10% of patients gained 15 or more letters of visual acuity at 12 months.
The study results also pointed to a favorable trend with respect to a reduced number of anti-VEGF injections following delivery of epimacular brachytherapy versus the period of time leading up to epimacular brachytherapy intervention. In addition, 25% of patients remained injection-free at 12 months following the procedure.
For more information, see the company’s website at www.neovistainc.com.